Vascular access device time sensitive status indication

ABSTRACT

A vascular access device for communicating with the vascular system of a patient may include a status indicator. The status indicator may detect and signal that a period of time has elapsed in relation to the use of the vascular access device.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.60/798,517, filed May 8, 2006, entitled VASCULAR ACCESS DEVICE STATUSINDICATION, and is incorporated herein.

BACKGROUND OF THE INVENTION

The present disclosure relates to infusion therapy with vascular accessdevices. Infusion therapy is one of the most common health careprocedures. Hospitalized patients as well as home care patients receivefluids, pharmaceuticals and blood products via a vascular access device(VAD) that may be inserted at least partially into the vascular system.Infusion therapy may be used to treat an infection, provide anesthesiaor analgesia, provide nutritional support, treat cancerous growths,maintain blood pressure and heart rhythm, or many other clinicallysignificant uses.

Infusion therapy is facilitated by a vascular access device. Thevascular access device may access a patient's peripheral or centralvasculature. The vascular access device may be indwelling for short term(days), moderate term (weeks), or long term (months to years). Thevascular access device may be used for continuous infusion therapy orfor intermittent therapy. A vascular access device is commonly a plasticcatheter that is inserted into a patient's vein, but may include anydevice employed to access the vasculature, such as a catheter, asyringe, a Luer adapter, an intravenous (IV) set, bag, or devicesattached thereto, a needle, or other related devices. The catheter maybe from a few centimeters in length for peripheral access to manycentimeters long for central access. A vascular access device may beinserted transcutaneously or may be surgically implanted beneath thepatient's skin. A vascular access device may have a single lumen ormultiple lumens for infusion of many fluids simultaneously.

The proximal end of the vascular access device commonly includes a Lueradapter to which other vascular access devices may be attached in orderto form an extravascular system. For example, an administration set ofone or more vascular access devices may be attached to a vascular accessdevice at one end and an intravenous bag at the other. Theadministration set is a fluid conduit for the continuous infusion offluids and pharmaceuticals. Commonly, an intravenous access device is avascular access device that may be attached to another vascular accessdevice. The IV access device closes the vascular access device andallows for intermittent infusion or injection of fluids andpharmaceuticals. An IV access device may comprise a housing and a septumfor closing the system. The septum may be opened with a blunt cannula ora male Luer of a medical device.

Complications associated with infusion therapy may cause significantmorbidity and even mortality. One significant complication is catheterrelated blood stream infection (CRBSI). An estimate of 250,000-400,000cases of central venous catheter (CVC) associated BSIs occur annually inUS hospitals. Attributable mortality is an estimated 12%-25% for eachinfection and a cost to the health care system of $25,000-$56,000 perepisode.

Vascular access device infection resulting in CRBSIs may be caused by anon-sterile insertion technique or by pathogens entering the fluid flowpath subsequent to catheter insertion. Studies have shown the risk ofCRBSI increases with catheter indwelling periods. This is due to a riskof contamination with every access of the vascular access device via anupstream port or IV access device. When contaminated, pathogens adhereto the vascular access device or IV access device, colonize, and form abiofilm. The biofilm is resistant to most biocidal agents and provides areplenishing source for pathogens to enter a patient's bloodstream andcause a BSI.

Recent studies have shown a potential correlation between the use of IVaccess devices and CRBSI rates. An IV access device is designed to closeanother vascular access device lumen between uses. Closure of thevascular access device supposedly prevents pathogens from infecting thevascular access device and causing a CRBSI. Contamination of an IVaccess device during use may originate from a variety of sourcesincluding a non-cleaned septum, a contaminated male Luer, or acontaminated infusion fluid. The contamination may result in pathogencolonization and biofilm formation which may cause a CRBSI if thepathogens enter the bloodstream. The risk of IV device contaminationincreases over time and with each use of the device.

Before accessing an IV access device, the top surface of the septum orvalve should be swabbed with an alcohol pad or other pad containing anantimicrobial agent. The swabbing cleans the surface of foreign materialand disinfects the surface. If the top surface is not swabbed andallowed to fully dry prior to use, foreign matter and pathogens may beintroduced to the interior of the device. The pathogens may colonize thedevice and catheter leading to biofilm formation. The pathogens of thebiofilm may breakaway and enter the patient's bloodstream resulting in aCRBSI. To ensure the highest ratio of foreign matter and pathogens arekilled, the alcohol or antimicrobial agent must be first applied andthen allowed to fully dry. Unfortunately, a large percentage of accessesof IV access devices are completed without swabbing and drying theseptum or valve top surface. Thus, what is needed are indicators toremind the operator to clean or replace the vascular access device toreduce the risk and occurrence of CRBSI.

BRIEF SUMMARY OF THE INVENTION

The present invention has been developed in response to problems andneeds in the art that have not yet been fully resolved by currentlyavailable vascular access devices and intravenous (IV) access devices.Thus, these developed systems and methods provide a vascular accessdevice, or IV access device, with a status indicator capable ofcommunicating a passage of time from when the vascular access device wasfirst placed into service, an amount of usage of the vascular accessdevice while in service, and/or disinfection of the vascular accessdevice.

A vascular access device for introducing a substance into a blood vesselof a patient includes a body with a lumen, a septum within the lumen,and a status indicator. The vascular access device may also include asecond vascular access device with a proximal end and a distal end. Thedistal end of the second vascular access device is introduced into theblood vessel, and the vascular access device is a connector affixed tothe proximal end of the second vascular access device. The statusindicator provides an indication of elapsed time using a time sensitiveadhesive, a color-changing substrate insulated with a variablytransmissive or variably permeable layer, a fluid absorbing material incontact with a series of separated dye, a colored liquid and a materialthrough which the colored liquid is transferred, a photochromic materialwhich includes an oxidizable material and/or a septum which includes aslit and an adhesive for sealing the slit.

The status indicator additionally or alternatively provides anindication of usage of the vascular access device which includes aratchet, a septum which includes an external surface and at least oneremovable layer of colored material on the external surface of theseptum, a bar code, a radio frequency identification chip, and/or apiezoelectric crystal.

The status indicator additionally or alternatively provides anindication of vascular access device disinfection which includes athermochromic material, a pH sensor, an alcohol sensor, a moisturesensitive compound, a colored substrate beneath a textured surface, areservoir of colored liquid, a piezochromic material, a polymer thatchanges color in the presence of intense ultraviolet light, and/or apathogen staining solution.

These and other features and advantages of the present invention willbecome more fully apparent from the following description and appendedclaims or may be learned by the practice of the invention as set forthhereinafter.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 is a perspective view of a vascular access device with a statusindicator.

FIG. 2 is a cross section view of a status indicator with atime-sensitive adhesive.

FIG. 3 is a cross section view of a status indicator with snap arms.

FIG. 4 is a cross section view of a status indicator with a clamp.

FIG. 5 is a cross section view of a set and unset adhesive statusindicator.

FIG. 6 is a cross section view of a set and unset spring anchored statusindicator.

FIG. 7 is a cross section view of a compression spring status indicator.

FIG. 8 is a cross section view of a status indicator with a wick anddye.

FIG. 9 is a cross section view of the wick and dye of FIG. 8.

FIG. 10 is a side view of the status indicator of FIG. 8 on the surfaceof a vascular access device.

FIG. 11 is a side view of a status indicator with a reservoir of coloredliquid on a vascular access device.

FIG. 12 is a cross section view of the reservoir of FIG. 11.

FIG. 13 is a side view of a strip status indicator on a vascular accessdevice.

FIG. 14 is a close up side view of the strip status indicator of FIG.13.

FIG. 15 is a cross section view of the strip of FIG. 14 taken alonglines 146-146 of FIG. 14.

FIG. 16 is a perspective view of a lightened photochromic vascularaccess device as a status indicator.

FIG. 17 is a perspective view of a darkened photochromic vascular accessdevice as a status indicator.

FIG. 18 is a perspective view of a lightened photochromic disk as astatus indicator attached to a vascular access device.

FIG. 19 is a perspective view of a darkened photochromic disk as astatus indicator attached to a vascular access device.

FIG. 20 is a perspective view of a label as a status indicator attachedto a vascular access device.

FIG. 21 is a side view of a label with multiple chemical reservoirs as astatus indicator.

FIG. 22 is a timing diagram of the visual change of a status indicator.

FIG. 23 is a cross section view of a status indicator on the slit of aseptum.

FIG. 24 is a side view of a ratchet status indicator of a vascularaccess device.

FIG. 25 is a top view of the ratchet status indicator of FIG. 24.

FIG. 26 is a cross section view of a multi-layered status indicator.

FIG. 27 is a close up cross section view of the multi-layered statusindicator of FIG. 26.

FIG. 28 is a perspective view of the top of a septum having amulti-layered status indicator.

FIG. 29 is a perspective view of the top of a septum having amulti-layered status indicator after use.

FIG. 30 is a side view of a bar code status indicator of a vascularaccess device.

FIG. 31 is a side view of a radio frequency identification chip statusindicator of a vascular access device.

FIG. 32 is a side view of a piezoelectric crystal status indicator of avascular access device.

FIG. 33 is a perspective view of a thermochromic status indicator layeron the top of a septum.

FIG. 34 is a perspective view of a pH sensor status indicator layer onthe top of a septum.

FIG. 35 is a perspective view of an alcohol sensor status indicatorlayer on the top of a septum.

FIG. 36 is a perspective view of a textured surface status indicatorlayer on the top of a septum.

FIG. 37 is a perspective view of a moisture sensitive status indicatorlayer on the top of a septum.

FIG. 38 is a cross section and top view of a dye transport reservoirstatus indicator before and after use.

FIG. 39 is a perspective view of a piezochromic status indicator layeron the top of a septum.

FIG. 40 is a cross section view of a loaded dual-chamber syringe statusindicator.

FIG. 41 is a cross section view of a partially ejected dual-chambersyringe status indicator.

FIG. 42 is a cross section view and a close up cross section view of astatus indicator of the inner surface of a vascular access device.

FIG. 43 is a front view of various status indicators in initial andfinal condition.

FIG. 44 is a schematic of various vascular access devices.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention will bebest understood by reference to the drawings, wherein like referencenumbers indicate identical or functionally similar elements. It will bereadily understood that the components of the present invention, asgenerally described and illustrated in the figures herein, could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description, as represented in thefigures, is not intended to limit the scope of the invention as claimed,but is merely representative of presently preferred embodiments of theinvention.

Referring now to FIG. 1, an intravenous (IV) access device and/orvascular access device 10 is used to introduce a substance into a bloodvessel of a patient. As described herein, a vascular access deviceincludes any device employed to access the vasculature, such as acatheter, a syringe, a Luer adapter, an IV set, bag, or devices attachedthereto, a needle, or other related devices. The vascular access device10 includes a body 12 with a lumen 14 and a septum 16 placed within thelumen 14. The septum 16 may have a slit 18 through which a device mayintroduce a substance into the lumen 14 of the vascular access device10. The device 10 also includes a status indicator 20 which will bedescribed with further detail in the following figures.

Referring now to FIG. 2, a status indicator 22 includes a time sensitiveadhesive 24 attached to a movable member 26 and to the body 12 of avascular access device 10. The movable member 26 is attached to thefirst end of a spring 28, and the second end of the spring 28 isattached to the body 12 of a vascular access device 10. The vascularaccess device 10 includes a window 30 through which the movable member26 may be seen by an operator of the device 10 when the device 10 is inuse.

An operator of the status indicator 22 may use the status indicator 22to learn how long the device 10 has been in use. When the device 10 isfirst attached to another vascular access device, such as a catheter orother structure that is placed within the blood vessel or vein of apatient, an operator, such as a patient, a physician, a clinician, anurse, or other healthcare professional, may allow the movable member 26to be pulled away from a stationary member 32 towards the spring 28.Eventually, the time sensitive adhesive 24 will permit the movablemember 26 to detach from the stationary member 32, causing the movablemember 26 to shift its position towards the spring 28. When the movablemember 26 is shifted from a first position to a second position, a redtag 34 will be placed within the viewing area of the window 30 throughwhich the operator can see the red flag 34. Upon viewing the red flag34, an operator will know that the device 10 has been in use for aspecific period of a lapsed time.

Referring now to FIG. 3, a status indicator 36 has one or more snap arms38 attached to the head 40 of a movable member 42. The movable member 42is in turn attached at its tail to a first end of a spring 44, and thesecond end of the spring 44 is attached to a body 12 of a vascularaccess device 10. The plastic snap arms 38 engage the head 40 such thatthe movable member 42 is secured by the snap arms 38 for a predeterminedamount of time. After a predetermined amount of time, the tension of theextended spring 44 causes the movable member 42 to pull upon the snaparms 38, which in turn causes the snap arms 38 to creep in a direction46 opposite the head 40 of the movable member 42. Ultimately, the snaparms 38 will creep far enough such that the movable member 42 will bereleased from the snap arms 38 and will move from a first position inthe snap arms 38 to a second position towards the spring 44 and awayfrom the snap arms 38. In the second position, the movable memberexposes a colored flag 48 through a window 50 of the body 12. When anoperator of the vascular access device 10 sees that the flag 48 isexposed within the window 50, the operator will know that a given periodof time has elapsed, indicating that the device 10 may need to becleaned or replaced.

Referring now to FIG. 4, a status indicator 52 includes a clamp 54 whichmay be removed by an operator to initiate the sequence of stepsillustrated in FIG. 2. Once the clamp 54 is removed from the statusindicator 52, a spring 56 which is connected to the body 12 of avascular access device 10 can pull a movable member 58 from a stationarymember 60 over a period of time. After an elapsed, predetermined amountof time, an adhesive 62 holding the movable member 58 to the stationarymember 60 will release, and the movable member 58 will move from a firstposition to a second position towards a spring 56. When the movablemember 58 moves into the second position, a flag 64 or other visible,colored structure, will be exposed through a window 66. When the flag 64is exposed through the window 66 of the device 10, an operator will knowthat a given period of time has elapsed, indicating that the device 10may need to be cleaned or replaced.

The clamp 54 shown in FIG. 4 permits an operator to initiate the timingsequence of the status indicator 52 at any point in time. By permittingthe operator to have control over when the status indicator is engagedby removing the clamp 54, an operator may choose to either engage thestatus indicator 52 upon first removing the device 10 from its sterilepackaging, upon first attaching the device 10 to another vascular accessdevice, or upon first using the attached device 10 by inserting a needleor other member to introduce a substance through the device 10 into ablood vessel of a patient.

Referring now to FIG. 5, a status indicator 68 may be delivered to anoperator within its packaging such that an adhesive 70 is not yetattached to a stationary member 72. At any point after removing thedevice 10 from its packaging, an operator may engage or set the statusindicator by pressing or otherwise placing a movable member 74containing the time sensitive adhesive 70 against the surface of thestationary member 72. When the status indicator 68 is set by theoperator, the operator initiates a time sequence by which the movablemember 74 is pulled with a spring 76 in a direction opposite the boundsurfaces of the movable member 74 and the stationary member 72.

Referring now to FIG. 6, a status indicator 78 may come disengaged on avascular access device 10 when the device 10 is still in its sterilepackaging. Similar to the status indicator 68 of FIG. 5, a user mayengage the status indicator 78 of FIG. 6 at any desired point of device10 operation. A spring 80 is compressed in a state where no tension orforce is placed upon the spring 80. The spring 80 is attached on a firstend to a movable member 82 and on a second end to an anchor 84. Themovable member 82 is attached to a stationary member 86 by means of atime sensitive adhesive 88. The anchor 84 may be set by an operator bymoving the anchor 84 in a direction 90 opposite the direction of themovable member 82. Upon moving the anchor 84 along a certain distance inthe direction 90, the anchor 84 is engaged with a notch 92. When theanchor 84 is fully engaged with the notch 92, an appropriate amount oftension and force is placed upon the spring 80 such that the movablemember 82 will detach from the stationary member 86 after an appropriatepredetermined amount of time, which indicates that the device 10 hasbeen in operation for an appropriate amount of time.

Referring now to FIG. 7, a status indicator 94 includes a compressionspring 96 attached on a first end to the body 12 of the device 10 and ona second end to a movable member 98. The movable member 98 is attachedon a bottom surface 102 to a top surface 104 of the body 12 of thedevice 10. The compression spring 96 is compressed while the movablemember 98 is adhered to the body 12. After a predetermined amount oftime, the adhesive 100 will release the movable member 98 from the body12 under the pressure and force of the compression spring 96. Whenmoved, the movable member 98 will expose a flag 106 within a window 108through which an operator may see the flag 106. When the operator seesthe flag 106 through the window 108, the operator will know that thedevice 10 has been in use for the predetermined amount of time.

Any one of the status indicators of FIGS. 2 through 7 can be initiatedby an operator in any number of ways when the device 10 is put intoservice. In one embodiment, the members may start together with a clampthat takes the load from the adhesive. The clamp is then removed at thestart of service. In another embodiment, the members start together, buta spring is not loaded until the start of service. In anotherembodiment, an operator presses the two members together at the start ofservice.

Any of these actions initiating the start of service for any of thestatus indicators discussed above can be coupled to other actions whichare commonly performed with a vascular access device. For example, adust cover protecting certain structures on the vascular access device10 may be removed after the device 10 is removed from its sterilepackaging or after the vascular access device 10 is attached to anotherdevice. The dust cover may be removed by pulling the dust cover from asurface of the body 12 of the vascular access device 10 or by twistingand pulling the dust cover from the device 10. The device 10 may also beremoved from the package, and a portion of the package may cause astatus indicator to begin the time sequence that places it in service.Further, as the dust cover is removed, a clamp may be removed with thedust cover, a spring may be loaded with the dust cover, or a movablemember may be placed into contact with a stationary member. Any otheraction performed by an operator of the device 10 can be combined toengage or disengage a status indicator.

The status indicators of FIGS. 2 through 7 may include any form ofvisual or mechanical indication as shown by example with the red flag 34of FIG. 2. The flag 34, or form of visual or mechanical indication, maybe any size, shape, or color and may include any mechanical structurecapable of indicating any lapsed period of time to an operator. Inaddition, multiple status indicators or multiple flags may be used in asingle device 10. In one embodiment, a device 10 includes a movablemember with multiple flags indicating multiple periods of time that haveelapsed.

In another embodiment, multiple movable members are attached to one ormore stationary members using multiple time sensitive adhesives ofvarying strengths and or amounts. The multiple adhesives release atdifferent time intervals, causing each of the multiple movable membersto be released in sequence and thus illustrating that certain timeperiods have elapsed to an operator. For example, a first movable memberwith a weak adhesive or an adhesive in a small amount, may firstdisengage from a stationary member to show an operator that 12 hourshave elapsed since the device 10 was placed in service. A second movablemember attached to a stationary member with a stronger adhesive than thefirst movable member or attached to a stationary member with a greateramount of adhesive may later detach from the stationary memberindicating to an operator that 24 hours have elapsed since the device 10was placed in service. This sequence may occur for a third andsubsequent movable members to indicate to an operator that variousperiods of time have elapsed.

Referring now to FIGS. 8 through 10, a status indicator 110 includes afluid absorbing material or a wick 112 and a series of separated dye114. The wick 112 is in contact with the dye 114 as shown in the crosssection view of the status indicator 110 which is placed on the body 12of the vascular access device 10. The status indicator 110 also includesan open port 116 to which a catheter or other fluid delivery system ordevice is attached. For example, a catheter attached to an IV bagdelivers water or saline to the open port 116, delivering a constantsupply of saline or water to the wick 112. In the alternative, thedevice may include an exterior fluid reservoir which is activated uponusage of the device. As time passes, the capillary forces of the wick112 draw water further along the length of the wick 112. As the water isdrawn along the wick 112, the dye 114 core is wetted, and the color ofthe water soluble dye 114 leaches through the wall of the wick 112 suchthat it is visible on the outer surface of the wick 112. The wetted dyeis visible through a viewing window 118 to an operator. As used aboveand as mentioned throughout this description and the claims, “usage”includes any use of a vascular access device or any structure incommunication with the device, including any use of or interaction withthe device, including disinfection, by a healthcare provider or otherindividual or with the environment after the vascular access device isremoved from its manufacturer packaging.

Referring now to FIG. 9, a cross section view of the wick 112 and watersoluble dye 114 is shown. As the wicking material or wick 112 is wetted,the dye 114 is dissolved and color migrates to the wicking material in adirection 120.

Referring now to FIG. 10, the status indicator 110 of FIG. 8 is shownembodied on the surface of a vascular access device 10. The statusindicator 10 shows the port 116 that is open to receive a fluid supply.The status indicator 110 also shows a serpentine path 122 through whichthe wicking material 112 and dye 114 travel. The entire length, or anyportion, of the path 122 may be viewable through the body 12 of thedevice 10 to an operator. The viewing window 118 of the status indicator110 as shown in FIG. 10, permits the operator to see when the dye 114 atthe end of the path 122 has been dissolved and has migrated to the wick112 in the viewing window 118. When the dye 114 is seen in the viewingwindow 118, an operator will know that a predetermined amount of timehas elapsed. The operator will then know that the operator should cleanand/or replace the device 10.

In one embodiment, the wicking material 112 is a weave of fabric or apaper wick with a water soluble dye core. In another embodiment, thepath 122 of the wick 112 and the dye 114 is not serpentine. Rather, thepath 122 is a straight line. The serpentine path 122 is preferablyspaced and has an adequate length to cover an entire desiredpredetermined time period for the status indicator 110. The path mayalso wrap around the entire device 10 in multiple revolutions. Inanother embodiment, the wick 112 is visible along the entire length ofits path. In another embodiment, the wick 112 is visible at discreetpoints along the length of the path. In the preceding two embodiments,the status indicator preferably includes marks on the surface of thebody 12 of the device 10 which indicate that various amounts of timehave elapsed since the device 10 was placed in service. As the dyedissolves along the path, the various time indicator points are reachedand are visible to an operator. In another embodiment, the dye 114 comesin various shapes, sizes, and colors. For example, along the path 122 afirst series of dye 114 may be colored green to indicate a first 12 hourperiod, a second series of dye 114 are colored yellow to indicate asecond 12 hour period from hour 12 to 24 and a third series of dye maybe colored red to indicate a third 12 hour period from hour 24 to 36.When the path turns red, an operator will know that the device shouldsoon or immediately be cleaned or replaced. The thickness and width ofthe wick material and dye and the size and spacing of the channel orpath in which the wick and dye are placed may be varied in order toadjust the rate and visibility at which the dye is dissolved anddisplayed to an operator along the path.

Referring now to FIG. 11, a status indicator 124 of a vascular accessdevice 10 includes a colored liquid 126 and a material 128 placed in achannel 130 through which the colored liquid 126 is transferred.

Referring now to FIG. 12, a cross section of the reservoir of coloredliquid 126 of FIG. 11 is shown located on the exterior surface of thebody 12 of the device 10. A seal 132 prevents the colored liquid 126from being absorbed by the material 128 until an operator exertspressure upon the reservoir of liquid 126. When an operator placespressure upon the colored liquid 126, the seal 132 is broken and thecolored liquid 126 is permitted to travel in a direction 134 along thematerial 128 until the colored liquid 126 is visible in a window 136 toan operator.

As shown in FIG. 12, the status indicator 124 is integrated into thedevice 10. In another embodiment, the status indicator 124 is a labelhaving a colored ink or colored oil as the colored liquid 126, and thelabel is attached to the device 10. In this embodiment, the colored inkor oil 15 initially contained in a reservoir that is obscured from viewvia a mask of the label. The ink or oil is then exposed to a porous orabsorbent material. The material is designed to wick the ink or oil at aspecified rate. Activation of the wicking may be accomplished by anoperator compressing the reservoir as discussed above. The compression,however, may not be accomplished by the operator's fingers. Rather, thecompression of the reservoir may be initiated in conjunction with use ofthe device 10 as it is placed in service or upon any other event capableof acting upon the reservoir. For example, the compression is caused byremoving a dust cover from the device 10. As another example, thecompression is caused when the device 10 is attached to another vascularaccess device providing access to a blood vessel of the patient. Bytwisting the device 10 onto another device, the force required to twistand attach the two devices together may also simultaneously compress thereservoir to initiate the travel of the colored ink or oil along theabsorbent material. At at least one point equivalent to a desiredelapsed time of wicking, the colored material is exposed to view in atleast one viewing window to an operator. In this manner, the materialchanges color and the operator is able to visualize the time based colorchange.

Referring now to FIG. 20, a label 162 as previously discussed, isattached to a vascular access device 10. The label 162 shows an elapsedtime period in numbers of days by advancing a strip of color across thelabel 162. In one embodiment, the label may be integrated into thedevice 10.

Referring now to FIG. 13, a status indicator 138 is a label adhered tothe exterior surface of the device 10.

Referring now to FIG. 14, the status indicator 138 is shown in furtherdetail. The label, or strip, of the status indicator 138 indicatesvarious time periods 140 along its length. The time periods 140 aredivided as follows: 12 hours, 24 hours, 36 hours, and 72 hours. When anyof these given periods of time have elapsed as displayed by the statusindicator 138 to an operator, the operator may either clean or removeand replace the device 10 depending on the specific needs of the patientand the environment in which the device 10 is used. The strip 142 is amulti-layered strip that is sensitive to light. When exposed to light,the strip 142 slowly begins to change color initially at a first end andthen the color change advances to a second end of the strip 142 in adirection 144. The rate at which the color travels in the direction 144may be modulated or adjusted or tuned, by overlaying a semi-transparentlayer over a color changing substrate as shown in FIG. 15.

Referring now to FIG. 15, a cross section of the strip 142 of FIG. 14 isshown along lines 146-146. The cross section of the strip 142 reveals acolor changing substrate 148 and a variably transmissive insulatinglayer 150 on top of the color changing substrate 148. The variablytransmissive layer 150 has a higher degree of transmissivity to light atits first end 152 and a lower amount of transmissivity to light at itssecond end 154. Between end 152 and end 154, the degree oftransmissivity to light of the layer 150 is graded from a higher to alower amount of transmissivity. Thus the transmissive layer 150 permitslight to communicate with the color changing layer 148 at a faster rateat end 152 than the light would communicate at the end 154. This permitsthe status indicator 148 to show an earlier color change at end 152 thanthe color change at end 154. The earlier color change is shown in FIG.14 as a colored band beginning at end 152 and traveling through the 12hour, 24 hour, 36 hour marks. However, because end 154 of FIG. 14 has alower level of transmissivity to light the light has not yet beenpermitted to communicate with the color changing substrate 148, and thestrip 142 does not yet show a color change at end 154.

In one embodiment, as shown with reference to FIGS. 13 through 15 above,the status indicator 138 is sensitive to light. In another embodiment,the status indicator is sensitive to oxygen. When exposed to oxygen, thestrip of the status indicator begins to slowly change color. In thisembodiment, rather than having a semi-transparent layer 150, the stripincludes a semi-permeable layer over the color changing substrate 148.The semi-permeable layer is permeable to oxygen. The semi-permeablelayer is variably permeable such that the first end of the strip willchange color before a second end of the strip changes color, indicatinga change in time during the use of the device 10. The color change willbegin at one end of the strip, and proceed along the length of the stripduring the period of elapsed time. In this manner, the position of theboundary between the colored and the non-colored portions of the stripbecomes an indicator of how long the strip has been exposed to oxygen.

In one embodiment, a light or oxygen sensitive strip is mounted on anadhesive backing and applied to any time sensitive device 10. The deviceis stored in a light or oxygen proof package to ensure that the stripdoes not initiate its time sequence until after the package is opened.Many of the embodiments discussed with reference to FIGS. 13 through 15appear much like a temperature-sensitive strip used in a fish tank.However, the colored band or strip indicates the passage of time ratherthan a change in temperature. The principals discussed in theseembodiments may be applied to indicate the passage of time, an amount ofuse of the device 10, or the disinfection of the device 10.

The oxygen sensitive material discussed above may be an oxidizablecompound that is covered by a substrate. The oxidizable compound may bea metal such as aluminum, silver, or magnesium. When oxidized, the metalmay turn a dark color or exhibit some other visual change. In oneembodiment, a layer that is semi-permeable to oxygen may cover theoxidizable compound. In another embodiment, the compound is compoundeddirectly into the layer. The layer is designed to have an oxygenpermeability rate controlling the timing of the oxidation of the metal.The layer and/or oxidative compound may contain an anti-oxidant tocontrol the timing of oxidation. The anti-oxidant will delay theoxidation reaction until the anti-oxidant is consumed. The oxidativecompound and layer may be incorporated directly into the device 10.Alternately, the oxidative compound and layer may be attached byadhesive to the device 10. Alternatively, the oxidative compound andlayer may be incorporated into a disk or other structure that can beattached to the exterior surface of the device 10. Multiple labels,disks, and/or bands of varying lengths may be used in combination on asingle device 10 to indicate the passage of multiple periods of time.

Referring now to FIG. 16, a status indicator 156 includes a photochromicmaterial forming the body 12 of a device 10. The photochromic material156 is a visual status indicator that shows a distinct change in colorfrom when the device 10 is first placed into service at initial use to aspecific lapse of time as mentioned above. For example, the photochromicmaterial 156 starts as a clear or white color upon initial use of thedevice 10. After the device 10 has been attached to a vascular accessdevice or otherwise placed in service for 24 hours, the photochromicmaterial 156 changes to a dark color 158 as shown in FIG. 17.

Referring now to FIG. 17, the dark photochromic material 158 of thedevice 10 indicates to an operator that the device 10 has been placed inservice for at least 24 hours and has reached an infection riskthreshold. The operator may then clean or replace the device 10.

The color change of the photochromic material 156 and 158 of FIGS. 16and 17 may be accomplished in a variety of embodiments. In oneembodiment, a photochromic dye is incorporated directly into the device10, to any portion thereof, or to any structure attached thereto.Photochromic materials may be used to, for example, indicate a passageof time during which a photochromic material has been exposed to lightor the lack thereof, indicate whether and to what extent a photochromicmaterial has been disinfected, and/or indicate whether and to whatextent a photochromic material has been properly cleaned. Photochromicdyes are commonly used compounds for non-medical device applicationssuch as eyeglasses and printing. When sunlight or ultraviolet (UV)radiation is applied, the dye becomes excited and the molecularstructure is changed allowing a color to appear.

Photochromic materials include a colorless isomer that contains a spirocarbon atom. This carbon atom is SP³-hybridized and serves to separatethe molecule into two halves. Because of the highly localized pi systemsthat are separated by a SP³-hybridized carbon, all absorption is in theUV part of the spectrum with none in the visible part of the spectrum,and hence the molecule appears colorless. When the molecule absorbs UVlight, the spiro carbon atom opens. The molecular structure then changesto one of extended conjugation and the molecule absorbs light in thevisible region. Many colors are possible through the mixing or four basecolors: blue, yellow, purple and orange/red. UV absorbing compounds maybe used in conjunction with the photochromic dyes to extend the time ofcolor shift.

The sensitivity of the ultraviolet material 158 may be modified and/ormodulated in order to provide a material that only changes color when inthe presence of an ultraviolet light of very high intensity. Thus anultraviolet light wand or other light source may be applied to the highintensity UV sensitive material 158 in order to change its color. Afterthe color is changed and the intense light source is removed, it mayreturn back to an original color after a predetermined amount of time.The intense source of ultraviolet light may be applied to the materialjust prior to, during, or after disinfection of the material.

A light source may be provided not only to change the color or providesome other visual change of a vascular access device, but a UV lightsource may additionally or alternatively be used to sterilize ordisinfect the device. UV rays or various intensities and wavelengths maybe used to kill or harm bacteria or pathogens on the device in order todisinfect the device. In such an embodiment, a UV wand or other devicemay be placed by a healthcare provider into communication with at leasta portion of a vascular access device in order to disinfect the device.The wand may remain in communication with the vascular access deviceuntil the device is disinfected. After disinfection occurs, thehealthcare provider may remove the UV wand.

A light source may also be used to confirm whether all or a significantnumber of pathogens have been killed. For example, a photochromicmaterial may require a completion of a color change in order to indicatethat all or a significant number of bacteria and pathogens have beencompletely killed on the light sensitive material. An operator is thenable to confirm whether the operator remembered to sterilize ordisinfect the device 10. For example, the absence of a bright or othercolor in the material indicates that the operator has forgotten thevital sterilization or disinfection step.

As shown in FIG. 17, the color change may also occur in anotherembodiment where the photochromic dye is incorporated into the device 10through addition of the dye to the polymer making the body 12 and/orseptum 16. The preferred housing polymer is polycarbonate but may beother clear or translucent polymers such as acrylic, polyvinylchloride,polypropylene, and polyurethane. The addition of the dye may occur atthe time the polymer is polymerized or during a subsequent compoundingoperation. The dye may also be added at the time of injection molding ofthe body 12 or septum 16.

In another embodiment, the photochromic dye may also be applied as acoating to the body 12 or septum 16. The dye may be mixed with a solventand the mixture sprayed, poured, atomized, printed, or dipped onto theappropriate surface. The solvent will evaporate leaving the dye on thesurface. The photochromic dye may also be printed onto a label and thelabel attached to the device 10.

Referring now to FIG. 18, a disk 160, as previously discussed, isattached to the exterior surface of the device 10. Referring now to FIG.19, the disk 160 has changed from a light color to a dark colorconsistent with the principles discussed herein.

In another embodiment, a status indicator may communicate an elapsedperiod of time to an operator through a transparency or refractive indexchange of a material forming the body 12 of the device 10. The change oftransparency of the substrate of the material may be initiated byoxidation, moisture absorption, or polymer crystallization. In thisembodiment, the substrate includes a compound that is sensitive tooxidation, and when oxidized, changes the substrate's refractive index.In another embodiment, the substrate is a material that absorbsmoisture. When the moisture content of the substrate reaches a specifiedamount, the substrate swells, causing a change in optical properties ofthe material. In another embodiment, a substrate polymer maycrystallize, causing an optical change such as a change in clarity ofthe material. In the embodiments above, the substrate may form the body12 of the device 10, may be a separate disk as shown in FIGS. 18 and 19,or may be a label as shown in FIG. 20.

Referring now to FIG. 21, a status indicator 164 is a label that may beattached to a device 10. The label includes a first chemical 166 and asecond chemical 168. The chemicals 166 and 168 are contained in separatereservoirs that are obscured from view of an operator via a mask of themulti-layer label 164. The status indicator 164 is activated bycompressing the reservoirs using either an operator's fingers or anaction that is performed in conjunction with installation, cleaning,attachment of the device 10 to another device, or other use of thedevice 10. Upon activation, the two chemicals 166 and 168 are mixed in achamber 170. Upon mixing, the chemicals react with each other and changecolors. The chamber 170 is viewable to an operator. When the operatorsees a change of color in the window of the chamber 170, the operatorwill know that a predetermined amount of time has elapsed. The twochemicals 166 and 168 may travel from their separate reservoirs into thechamber 170 by means of a porous or absorbent material or by means ofmicro fluid channels 172 and 174. In another embodiment, a change of pHwhen the two chemicals 166 and 168 are mixed results in a color changewithin the chamber 170. In another embodiment, the reservoirs containingthe chemicals 166 and 168 are separated from each other and/or from thechamber 170 using a breakable seal similar to seal 132 described earlierwith reference to FIG. 12.

In another embodiment, a device 10 package is resistant to theenvironmental factors that initiate a time sequence of any of the statusindicators discussed herein. Depending on the particular statusindicator, the package includes a barrier to light, oxygen and/or othergasses, and moisture, as appropriate. The package may also include amechanism to initiate the time sequence of the particular statusindicator upon removal from the package.

The status indicator time sensitive signals, discussed above, that arecommunicated to an operator, correlate with the risk level that has beenshown to result in catheter related blood stream infections (CRBSIs) ifexceeded. The activation time for the signal may be different, dependingupon device 10 application. As stated previously, the risk ofcontamination and pathogen colonization increases with device 10 usage.For devices used in a high use application such as an intensive careunit (ICU), a short (24 hours) time sensitive status indicator will beused. For medium use applications, the activation time may be 48 hours.And, for minimal use applications the signal activation time may be 72hours to 96 hours, or greater.

Referring now to FIG. 22, as discussed above, a status indicator may bea color change or may be a change of other visual properties, such astransparency. In one embodiment, the visual change timing will follow ans-shaped curve 176. As shown in FIG. 22, there will be no, or minimal,change for a specified period of time 178, and then the visual changewill be quick, intense, and non-reversible for a separate period of time180. The activation of the visual change 182 may be delayed to thedesired time frames discussed herein. Initiation of the time sensitivestatus indicator may occur by exposing the status indicator toenvironmental factors such as light, air, and moisture as discussedherein. Initiation may also occur upon removing the device 10 from itssterile package, initial usage or actuation of the device 10 throughnormal or deliberate use, or by manual or other actuation of theoperator.

Referring now to FIG. 23, the septum 16 of the vascular access device 10of FIG. 1 is shown. The septum 16 includes a slit 18 through which aneedle, catheter, or male Luer may be inserted into the device 10. Thesurface of the slit 18 may be coated with a lube or adhesive 184. Thelube or adhesive 184 as shown in FIG. 23 is a cross-linking siliconelube that glues or otherwise adheres the slit 18 shut after a givenamount of time. The silicone cross-linking of the silicone material thatforms the body of the septum 16 can be initiated, initialized, orcatalyzed by enzymes produced by a bacteria or other pathogen. After aperiod of time, the septum 16 of the device 10 is colonized by bacteriaor other pathogen, and the slit 18 is glued shut by the lube 184, thusblocking access of a needle, catheter, male Luer, or other device thatan operator may desire to insert through the septum 16. Thus, in theembodiment of FIG. 23, a status indicator 186 is a mechanical indicatorthat prevents an operator from further accessing the septum 16 after apredetermined amount of time. The type and amount of adhesive or lube184 that is used and the location at which the lube or adhesive 184 isapplied along the length of the slit 18 may be varied to adjust thespeed or rate at which the slit is sealed.

Alternatively, the adhesive may be time sensitive due to moisturesensitivity. The adhesive gradually absorbs moisture over apredetermined period of time. Once moisture is absorbed to a specificlevel the slit 18 may be glued shut as discussed above.

In addition to the embodiments discussed above with reference to FIGS. 1through 23, a status indicator can indicate an amount of use by anoperator in addition to or in place of an elapsed period of time.Embodiments of status indicators which can communicate usage of a device10 to an operator are discussed with reference to the following figures.

Referring now to FIG. 24, a status indicator 188 provides an indicationof usage of a vascular access device 10. The status indicator 188includes a ratcheting mechanism 190 that includes a ratchet 192 thatcommunicates with multiple sequential teeth 194 of the ratchetingmechanism 190. As the ratchet 192 articulates between the multiplesequential teeth 194, the ratchet 192 is advanced from a first positionto a second position in a direction 196 along the device 10.

Referring now to FIG. 25, a top view of the status indicator 188 isshown. The device 10 is often accessed by another device from adirection shown in the view of FIG. 25. When another device, such as aneedle, catheter, or male Luer, accesses the device 10, the ratchet 192,which is spring loaded, is moved from a first elevation to a secondelevation and articulated from a first tooth 194 to a second tooth 194causing the ratcheting mechanism 190 to rotate the pointer 198 of theratchet 192 to move along in a direction 196 as shown in FIG. 24. Thus,the ratcheting mechanism 190 may be used to sense an amount of usage ofthe device 10 as it is mated, combined, or otherwise accessed by otherdevices. Each time a device accesses device 10, the pointer 198 of theratchet 192 will advance in a direction 196 to indicate that the device10 has been accessed again. As shown in FIG. 24, a counter 200illustrates to an operator the number of times the device 10 has beenaccessed by an operator. By viewing the counter 200 and the location ofthe pointer 198 in relation to the counter 200, any operator viewing thedevice 10 can understand the history of the usage of the device 10without ever having seen the device or interacted with the patientduring the life of the device. The status indicator 188 and ratchetingmechanism 190 of FIGS. 24 and 25 functions very similarly to theclicking mechanism of a pen. Any similar mechanism capable of indicatingthe usage of the device 10, including the ratcheting mechanism of a pen,may come within the scope of the status indicator 188 as describedherein. The ratchet 192 and/or the pointer 198 may be any size, shape orcolor and may become visible in any window, or series of windows, or maybe visible along the entire body 12 of the device 10.

Referring now to FIG. 26, a septum 16 of a vascular access device 10includes a status indicator 204 on the top external surface 202 of theseptum 16. The status indicator 204 includes at least one removablelayer of colored material on the external surface 202 of the septum 16.

Referring now to FIG. 27, an exploded cross-section view of the statusindicator 204 of the septum 16 of FIG. 26 is shown. The status indicator204 includes multiple layers 206 of different colored materials. A firstlayer 208 is colored green, a second layer 210 is colored yellow, and athird layer 212 is colored red.

Referring now to FIG. 28, initially, the surface 202 of the septum 16 iscoated with all three layers of soft and easily abraded coloredmaterial. The material may also be slightly alcohol soluble. Thus, thestatus indicator 204 of FIG. 28, shows a top green layer 208 of materialat its most external surface.

Referring now to FIG. 29, after an operator abrades, actuates, swabs, orotherwise disturbs the top surface 202 of the septum 16, the top greenlayer 208 will be removed and the middle yellow layer 210 will beexposed. After further access and use of the device 10, the yellow layer210 will be removed, exposing the red bottom layer 212. When any or allof the top surface 202 is shown as a red 212 color to the operator, theoperator will know that the device 10 has received a certain amount ofusage. The operator may then choose to clean and/or replace the device10.

In one embodiment, the status indicator 204 of FIGS. 26 through 29includes a material that is soluble to alcohol. Operators often swabalcohol on the exterior surface 202 of the septum 16 in order to cleanthe device 10 and kill any bacteria or other pathogens that are on thesurface 202 of the septum 16 or within the slit 18 of the septum 16. Byallowing the layered material to be slightly alcohol soluble, thematerial can change color, texture, and/or shape in order to visuallycommunicate to an operator that the device 10 has been swabbed one ormore times. In another embodiment, the material may be an easily abradedcolored material which when touched, swabbed, or otherwise accessed ordisturbed, changes color or shape. In another embodiment, multiplelayers 206 having multiple characteristics including alcohol solubility,saline solubility, water solubility, and abrasion, may be stacked uponeach other to achieve a variety of affects in order to tailor the septum16 and the status indicator 204 to a particular use within a hospital.

Referring now to FIG. 30, a status indicator 214 includes a bar codelabel 216 secured to a vascular access device 10. When the device 10 isput into service, and each time the device 10 is accessed, an operatorscans the bar code 216 with a bar code scanner to keep track of the timethe device 10 is in use and the number of times the device 10 has beenaccessed. A database within the bar code scanner or other device capableof receiving data from the bar code scanner provides an alarm wheneither time or access limits are reached. For example, after 24 hoursafter the device 10 was initially scanned in a first time, a device mayprovide an alarm to the operator which indicates that the device 10 hasbeen in use for at least 24 hours. Alternately or additionally, an alarmwhich indicates that a maximum number of accesses has been reached mayalso be communicated to an operator. The bar code 216 may come in theform of a label or hang tag or other structure that it is attached,affixed, or otherwise secured or connected to the device 10.

Referring now to FIG. 31, a status indicator 218 includes a radiofrequency identification (RFID) chip 220. The RFID chip 220 is placed onthe external surface of a vascular access device 10. The RFID chip 220permits the device 10 to store information relative to the amount oftime the device 10 has been in service and/or the number and frequencyof accesses or uses of the device 10. A scanner is used to signal thechip 220 when the device 10 is put into service, and each time the chip220 is accessed, so that the chip 220 can record the data. The scannercan also read the start time and the number of accesses from the chip220. Thus, the embodiment of FIG. 31 of a status indicator 218 providesan advantage over the status indicator 214 of FIG. 30, because theinformation is stored in the chip 220 of the device 10 and not in remotedatabase of a bar code scanner or other device. A number of differentscanners can access and manipulate the information on the device 10without requiring a single scanner to follow the device 10 or withoutrequiring a link to a central remote database. Thus, each of a number ofdifferent operators who come into contact with the device 10 may havetheir own separate scanner and can learn about the history of the device10 independently.

Referring now to FIG. 32, a status indicator 222 includes apiezoelectric crystal 224 in series with an RFID chip 220. Thepiezoelectric crystal 224 senses when the device 10 is activated andproduces a small amount of electrical charge when the crystal iscompressed by use of the device 10. The charge produced by the crystal224 is detected by the RFID chip 220, and the RFID chip increments thecounter based on the number of accesses or uses. Thus, the embodiment ofthe status indicator 222 of FIG. 32 does not require a separate scannerto indicate whether or not the device 10 has been used. Rather, the RFIDchip 220 senses each use of the device 10 upon compression of the deviceby the handling of an operator. A scanner is only required to be used inorder to retrieve the collected information of the RFID chip 220.Various other circuits and electrical components in addition to thoseillustrated in FIGS. 30 through 32 are possible.

In addition to the multiple embodiments discussed herein directed todetecting the time and usage of a device 10, other embodiments of statusindicators described herein can provide an indication of disinfection,sterility, cleanliness, or the presence or absence of a bacteria orother pathogen in or on a device 10.

Referring now to FIG. 33, a status indicator 226 includes athermochromic material 228 on an external, swabbable surface 230 of aseptum 16 of a vascular access device 10. The thermochromic material 228is applied as a coating on the septum 16. In another embodiment, thematerial 228 is applied as a compound into the material of the septum 16itself. The thermochromic material 228 is a status indicator 226 thatprovides a reversible indication of cleaning and disinfecting. Uponswabbing the surface 230 with alcohol or another rapidly evaporatingliquid, the surface 230 changes color temporarily to another colorindicating that the device 10 has been cleaned. After accessing thedevice 10, and after the alcohol or other liquid is fully evaporated,the color of the thermochromic material 228 will change to its originalcolor.

The color change may be accomplished via thermochromism which is theability of a substance to change color due to a change in temperature.Two thermochromic approaches are based upon liquid crystals and leucodyes. Liquid crystals are capable of displaying different colors atdifferent temperatures. The crystalline structure of the materialchanges as the temperature changes resulting in selective reflection ofcertain wavelengths. The crystals will assume the original structureupon return of temperature to the starting point. Therefore, the colorof thermochromic liquid crystals is changeable and reversible. Liquidcrystals may be encapsulated in microcapsules.

A leuco dye is a dye whose molecules can acquire two forms, one of whichis colorless. For example, the spiro form of an oxazine part of themolecule is separated by a SP³-hybridized, or spiro, carbon. Anillustrative example includes microcapsules with crystal violet lactone,weak acid, and a dissociable salt dissolved in dodecanol areencapsulated. When the solvent melts, the salt dissociates, the pHinside the microcapsule lowers, the dye becomes protonated, its lactonering opens, and its absorption spectrum shifts drastically causing thedye to become deeply violet.

Another thermochromic material is polythiophene. Chains of apolycrylamide derivative are attached to a polythiophene backbone. Atlower temperatures the chains are irregular and stretched out. As thetemperature is increased the chains and backbone pull into a compactspherical structure. This conformational change causes a color change oforange-red to yellow.

As shown in FIG. 33, in use, an operator prepares to access the device10 by swabbing the top surface of the septum 16 with an alcohol wipe orsimilar disinfecting tool. Following swabbing, the alcohol applied tothe surface 230 begins to evaporate. As the alcohol evaporates, thesurface temperature decreases, causing the thermochromic material 228 tochange color. The color change may be a status indicator 226 to theoperator that the septum 16 disinfected and the device 10 is ready foraccess. As the temperature of the septum surface returns to roomtemperature, the color change reverses, returning to the original coloror no color.

70% isopropyl alcohol evaporating from a stainless steel surface maycause a temperature shift of 20 degrees F. The septum 16 and coating maybe made from a polymer. However, polymers do not have good thermalconductivity. Therefore, the temperature change caused by theevaporation of alcohol from a polymer surface may not be as large asthat from stainless steel. Thus, metal nanoparticles may be added to theseptum 16 material or coating to improve thermal conductivity.

Referring now to FIG. 34, a status indicator 232 includes at least onepH sensor 234. The pH sensor 234 is located on the exterior surface 230of the septum 16 of a device 10. The pH shift can indicate whether ornot the septum 16 has been swabbed with a substance containing a pHwithin a specific range. The pH of 70% isopropyl alcohol in water isbetween five and six. A reversible pH sensor 234 sensitive to a pH rangeof five to six is integrated into the swabbing surface 230 by a coatingor by compounding the sensor 234 into the material of the septum 16.Upon swabbing the surface 230, the alcohol solution causes the pH sensor234 to change colors indicating that the device 10 has been disinfectedand is ready for access. Following evaporation of the alcohol solution,the pH of the swabbing surface 230 will shift outside the sensor rangeof five to six, and the sensor 234 will return to a baseline color.

Referring now to FIG. 35, a status indicator 236 includes an alcoholsensor 238 on the surface 230 of a septum 16 of a vascular access device10. The alcohol sensor 238 initiates a color change caused by a chemicalreaction between a chemochromic compound and alcohol solution or otherdisinfecting agent. The chemochromic compound of the alcohol sensor 238may be integrated into the swabbing surface 230 via coating or may becompounded into the material of the septum 16 itself. Upon swabbing thesurface 230 with alcohol, the alcohol solution reacts with thechemochromic compound, causing a color change and indicating that thedevice 10 has been disinfected and is ready for access. Followingevaporation of the alcohol solution, the reaction would reverse and thechemochromic compound of the sensor 238 would return to a baselinecolor. An alcohol indicator consisting of a carrier matrix with analcohol oxidase enzyme which catalyzes a reaction converting alcohol toan oxidizing agent, and a hydrogen donor indicator which changes colorwhen oxidized, may be used. Examples of hydrogen donors include2,2′-azinodi-(3-ethylbenzthiazoline sulfonic acid);3-methyl-2-benzothiazolinone hydrazone and 3-dimethylaminobenzoic acid;3,4-dichlorophenol and 4-aminophenazone, o-tolidine; and o-tolidine anddianisidine.

Several other additional or alternative chemicals may be identified ordeveloped to exhibit a reversible or irreversible color change whenexposed to alcohol, chlorhexadine gluconate (CHG), or other commondisinfectants. Several companies currently produce test strips thatreact to the alcohol that is present in saliva after alcohol has beenconsumed. One such strip is produced by Chematics and is named theALCO-SCREEN™ test strip. The ALCO-SCREEN™ test strip will turn green orblue when exposed to saliva containing alcohol. With higherconcentrations of alcohol than that found in saliva, the strip willturn, through a chemical reaction, to a dark brown or black color. Sucha strip in another embodiment, may be applied to the surface of theseptum 16 or any portion of the device 10.

Referring now to FIG. 36, a status indicator 240 includes a texturedsurface 242 on the surface 230 of a septum 16. Beneath the texturedsurface 242, lies a colored substrate 244. When the textured surface 242is swabbed with alcohol, water, or another disinfectant or liquid, theliquid is absorbed by the textured surface 242 and the contact surface242 becomes nearly transparent. In its transparent state, surface 242provides a window through which an operator may view the coloredsubstrate 244. In this manner, a surface which is nearly frosted,opaque, or otherwise obscured when a surface finish is applied, becomesa transparent window to a more visible colored substrate when thesurface is wetted. Thus, when the surface 242 is wetted, it will appearto take on the color of the submerged surface or colored substrate 244.After the liquid evaporates fully, the surface 242 will again appearfrosted, opaque, or otherwise obscured.

Referring now to FIG. 37, a status indicator 246 includes a moisturesensitive layer 248 on the surface 230 of a septum 16. The moisturesensitive layer 248 may also be a moisture sensitive compound fullyintegrated with the material of the septum 16. Upon swabbing the surfaceof the moisture sensitive layer 248, the water of an alcohol solutionmay be absorbed by the moisture sensitive layer 248 causing a change incolor and indicating that the device 10 has been disinfected and isready for access. Following evaporation of the water of any liquid, themoisture sensitive layer 248 returns to a baseline color. Desiccants arean example of moisture sensitive layers or compounds. Many desiccantschange to a blue color upon absorption of water and then return to abaseline color when the moisture is removed.

Referring now to FIG. 38, a status indicator 250 includes a reservoir ofcolored liquid 252 with an elastomeric septum 16 of a vascular accessdevice 10. The reservoir contains either an opaque white liquid or acolored dye. When properly designed, the reservoir is partially or fullyevacuated when exposed to pressure on a surface 230 of the septum 16during normal cleaning and use. The fluid 252 is then displaced into astorage reservoir under pressure. When the pressure is released, thefluid 252 will slowly flow back from the holding reservoir 254 into theoriginal reservoir 256. FIG. 38 shows a top view 258 of the originalreservoir 256 prior to use of the septum 16. The original reservoir 256is shown in a dark color. After cleaning or use of the septum 16, a topview 260 shows the original reservoir 256 evacuated of the colored dye252, thus leaving the original reservoir 256 as a lighter color than theoriginal reservoir 256 of top view 258.

As shown in FIG. 38, the device 10 has a surface 230 that changes colorwhen exposed to temperature change, alcohol, or other disinfectant. Thedevice 10 then changes color back to the original color after anappropriate amount of time that would correspond to the time requiredfor the disinfectant to evaporate and completely kill a bacteria orother pathogen. This would enforce two important behaviors foroperators: first, proper and full disinfection, and second, waiting anappropriate amount of time before inserting a device into the septum 16.The rate at which the surface 230 is changed from a dark color to alight color may be adjusted by varying the type of liquid or othermaterial placed within the reservoir, the size of the reservoir, thecolor of the material, and/or the dimensions and materials of the bodyof the septum 16.

Referring now to FIG. 39, a status indicator 262 includes a piezochromicmaterial 264. The piezochromic material 264 is a material which willchange color when exposed to pressure. The material 264 may be coated asa layer on a surface 230 of a septum 16. In another embodiment, thematerial 264 may be embedded into the surface of the septum. In yetanother embodiment, the material 264 may be integrated into the materialof the septum 16 as a compound. When proper disinfective swabbing occurson the surface 230, the pressure caused from the swabbing action wouldcause the surface 230 to change color. As the pressure is removed, thesurface 230 would return to its original color. This approach, like manyother surface contact approaches described herein, encourages anoperator to disinfect the entire surface of the corresponding statusindicator.

Referring now to FIG. 40, a status indicator 263 includes a pathogenstaining solution 265 or other reagent. The solution 265 is placedwithin a dual chamber syringe 266 containing both the solution 265 and acleaning saline solution 268 divided by a movable stopper 270. Thesyringe 266 includes a plunger 272 and at least one notch 274 into whichthe movable stopper will collide as the plunger 272 is advanced throughthe lumen of the syringe 266.

Referring now to FIG. 41, the plunger 272 of FIG. 40 is shown advancedthrough the syringe 266 such that the movable stopper 270 has advancedand collided with the notches 274. In its advanced state, the plunger272 has expelled the solution 265 into a vascular access device 10 andthe leakage 276 caused by the collision of the movable stopper 270 withthe notches 274 has permitted a saline solution 264 to leak past themovable stopper 270 and into the device 10.

An operator may attach the syringe 266 of FIGS. 40 and 41 to a device 10and flush the syringe 266 as the operator would with any normal syringe.A main stopper 278 attached to the end of the plunger 272 pushes thesaline 268, which pushes on the movable stopper 270, which in turnpushes the pathogen staining solution 265 into the device 10. Thepathogen staining solution 265 stains all the microorganisms andpathogens as it passes them. When the staining solution 265 is fullyflushed into the device 10, the movable stopper 270 reaches the notches274 in the barrel of the syringe 266 allowing the saline 268 to leakpast the movable stopper 270 and into the device 10. The saline 268 thenflushes the staining solution 265 from the device 10 leaving the device10 clear. Any microorganisms in the device 10 will now be stained andvisible to an operator. In this manner, a device 10 and any other deviceto which the device 10 is attached may be checked for disinfection andthe absence of pathogens each time the status indicator 263 is employed.As another embodiment, notches 274 may be supplemented or replaced bygrooves or other recesses within the material of the barrel of thesyringe 266. Fluid, such as saline 268, may flow through the grooves orrecesses when the movable stopper 270 is in communication with thegrooves or recesses.

Referring now to FIG. 42, a close-up view shows a status indicator 280disposed on the inner surface 282 of the body 12 of a vascular accessdevice 10. The status indicator 280 includes a fluid activated dye 284substrate beneath a degradable membrane 286. The chamber 288 within thedevice 10 fills with fluid 290 when the device 10 is placed in service.The fluid 290 in the chamber 288 comes into contact with the innersurface 282, causing the degradable membrane 286 to dissolve or degradeover a controlled period of time, thus exposing the fluid activated dye284 to the fluid 290. When the fluid activated dye 284 changes color orotherwise causes the fluid 290 to change color, an operator will knowthat the device 10 has been exposed to fluid 290 and placed into servicefor a given period of time. The rate at which the degradable membrane286 degrades or dissolves may be adjusted to produce the desired timingeffect by varying the material properties, thickness, and location ofapplication of the membrane 286 to the device 10.

In one embodiment, the status indicator 280 of FIG. 42 includes a coloror other mechanism to alert an operator that the device 10 has expired.In another embodiment, the status indicator 280 of FIG. 42 includes amoisture sensitive layer or other fluid activated indicator in place ofthe fluid activated dye 284. When the moisture sensitive layer isexposed to the fluid 290, the layer will indicate to an operator that agiven period of time has elapsed. In another embodiment, the statusindicator 280 includes a lube or adhesive similar or identical to thelube or adhesive 184 discussed with reference to FIG. 23. In thisembodiment, the lube or adhesive and the degradable membrane 286 areplace on the exposed surface of the slit 18 of the septum 16. After thedegradable membrane 286 is removed, the lube or adhesive will cause theslit 18 to seal, thus blocking further use and access of the device 10to an operator.

In conjunction with any of the elements discussed here, further examplesof status indicators may be provided. For example, a status indicatorrelated to a label or other indicator capable of displaying a visualchange over time may be provided in addition to, for example, the statusindicators discussed with reference to FIGS. 13-22. Some of theseexamples of status indicators are discussed below.

Referring now to FIG. 43, a device 10 may include at least one statusindicator 292, 294, 296, 298, 300, 302, 304, and/or 306 in anycombination. After an environmental, physical, temporal, or other changeoccurs, such as a change in light (using photochromic dyes ormaterials), oxygen level, temperature, use, cleaning, or time aspreviously discussed (for example, using dye migration that becomesvisible over time), the status indicators 292, 294, 296, 298, 300, 302,304, and/or 306 change from an initial condition 308 towards a finalcondition 310. In an initial condition 308, the status indicators 292,294, 296, 298, 300, 302, 304, and/or 306 indicate that no significantchange in environment, physical use, time, or other event has occurred.

For example, a temporal change (i.e., a change in time) may be recordedand displayed for a period of 24 hours as shown by status indicators 292and 294, a period of 48 hours as shown by status indicator 296, a periodof 72 hours as shown by status indicators 298 and 306, or a period of 96hours as shown by status indicator 300. Any combination of multiple timeperiods may be recorded and displayed. For example, the statusindicators 302 and 304 each record and display the multiple sequentialtime periods of 24, 48, 72, and 96 hours.

For temporal change, any time period may be measured as desired by aparticular use, prescribed use, treatment regime, facility policy,industry guideline or recommendation, or as required by law. Forexample, 24 hours may be recorded and displayed on a label attached to acatheter or other tubing used for lipid-infusion. Such labels may beidentified for measuring “lipids” or “TPN” (i.e., total parenteralnutrition), as shown by status indicator 292. 48 hours may be recordedand displayed on a label attached to any portion of an IV set ifdirected by the policy of the particular facility in which the label isbeing used. 72 hours may be recorded and displayed on a label attachedto any portion of an IV set or other vascular access device inaccordance with infusion safety standards and recommendations of theInfusion Nurses Society. And, 96 hours may be recorded and displayed ona label attached to any portion of an IV set or other vascular accessdevice in accordance with guidelines by the Center for Disease Control.

After a change in environment, physical use, or time has occurred, thestatus indicators will display a visible change, for example, bydarkening or coloring at least a portion of the status indicators 292,294, 296, 298, 300, 302, 304, and/or 306 until such change is ultimatelyshown as represented in the final condition 310 for each statusindicator 292, 294, 296, 298, 300, 302, 304, and/or 306. Such visualchange may occur as a rapid change from one color to another, as shownby comparing the initial condition 308 with the final condition 310 ofstatus indicators 292, 294, 296, 298, and 300 and as represented in thegraph of FIG. 22. Such visual change may occur as a rapid change atspecific time intervals, as shown by comparing the initial condition 308with the final condition 310 of status indicator 304. Such visual changemay occur as a darkened word 312 such as “REPLACE”, as shown bycomparing the initial condition 308 with the final condition 310 ofstatus indicator 306.

Such visual change may occur as a gradual, gradient, color changeindicating a gradual change in environment, physical use, or time, asshown by comparing the initial condition 308 with the final condition310 of status indicator 302. As shown in the final condition 310 ofstatus indicator 302, a portion representing a period of 24 hours iscompletely darkened, indicating that a passage of 24 hours has certainlyoccurred, and a portion representing period of 96 hours has not darkenedto any degree, indicating that a period of 96 hours has certainly notoccurred. A majority of the portion representing a period of 48 hours isdarkened, indicating that a period of 48 hours has likely occurred, anda minority of a portion representing a period of 72 hours is darkened,indicating that a period of 72 hours has not likely occurred. Statusindicator 302, as shown in final condition, is not necessarily in finalcondition. That is, after a period of 96 hours has elapsed, statusindicator 302 should be entirely darkened in its final condition.

A health care provider may attach or replace any one or more labels orstatus indicators to any vascular access device, and/or the labels orstatus indicators may be already secured to or integral to the devicesprior to access by the health care provider.

As discussed herein, a vascular access device, such as device 10, mayinclude any device capable of providing therapy to the vascular systemof a patient. Various examples of vascular access devices are providedherein. By way of further example and with reference to FIG. 44, avascular access device may include any one or more of the followingstructures, taken alone or in any combination, and any other structurein communication with any of the following structures: an IV and/or dripchamber assembly 320 including a spike 322, a spike cover 324, a ventsuch as a spike vent 326, a cannula or catheter 328, a clamp including aslide clamp 330, a snap clamp 332, or a roller clamp 334, a burette 336,a burette vent 338, a burette fill port 340, a drug run preventionbarrier 342, a drip chamber 344, a filter 346, a safety strap 348, an IVhook 350, a valve such as a check valve 352, an injection site and/orLuer connector 354, a Y-port 356, an access port including a needleaccess port 358, a blunt can access port 360, a Luer access port 362, aT-site manifold 364, a stop cock 366, or a stop cock manifold 368, apump including a pump cartridge 370, an air or particulate filter 372including a vent 374, a flow regulator 376 such as a precision flowregulator, a flash bulb 378, an air trap 380, a slip Luer 382, a capsuch as a dust cap 384, a Luer lock 386, a vent cap 388, a universalLuer 390, a needle tip cannula 392 or catheter tip cannula, a needle tipguard or shield 394 or catheter tip guard or shield 396, and/or a needleset such as a wing needle set 398.

Hundreds, if not thousands, of vascular access devices exist or may bedeveloped in the future. The vascular access devices described hereinform merely an abbreviated list of some vascular access devices to whichthe principles and elements of the claimed invention may be applied. Theprinciples and elements of the claimed invention may be applied to anystructure discussed above, to its equivalents, or to similar,after-arising technology. Specifically, a status indicator may be placedin communication with any vascular access device to detect and/orcommunicate an event or passage of time helpful to a caregiver, such asthe passage of time during which the device has been in use, an amountof usage of the device, whether or not the device has been cleaned,disinfected, or sterilized, and/or whether and to what extent one ormore pathogens reside at or near the device.

Many of the embodiments discussed above have been described to includeeither reversible or non-reversible changes of status indicators. Forexample, a color change from a first color to a second color may reversefrom the second color to the first color after a period of time or theoccurrence of a certain event. Although not every example of reversiblestatus indicators has been provided here, any claimed embodiment,whether described as reversible or non-reversible, or described withoutrespect to reversibility, may be capable of reversing from a secondstate back to a first state or from a second state to an additionalthird state and is intended to come within the scope of the claimedinvention.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Forexample, the elements discussed above may be combined in any number andorientation in an enabling manner with any number and orientation of anyof the other elements discussed above to produce a status indicator fora vascular access device. The described embodiments are to be consideredin all respects only as illustrative, and not restrictive. The scope ofthe invention is, therefore, indicated by the appended claims, ratherthan by the foregoing description. All changes that come within themeaning and range of equivalency of the claims are to be embraced withintheir scope.

1-22. (canceled)
 23. A vascular access device comprising: a body; achannel within the body, the channel having a first end, a second end, alength, and inner dimensions; a liquid absorbing material disposedwithin the channel; a liquid source in fluid communication with thefirst end of the channel; and the length and inner dimensions of thechannel being configured so that a liquid from the liquid source movesfrom the first end of the channel through the liquid absorbing materialto the second end of the channel in approximately a predetermined amountof time.
 24. The vascular access device of claim 23, further comprisinga widow disposed between the second end of the channel and an externalenvironment, the channel being visible through the window.
 25. Thevascular access device of claim 23, further comprising a plurality ofwidows disposed between the channel and an external environment, thechannel being visible through the windows.
 26. The vascular accessdevice of claim 23, further comprising a water soluble dye within thechannel.
 27. The vascular access device of claim 23, wherein the innerdimensions of the channel change along the length of the channel. 28.The vascular access device of claim 23, wherein the predetermined amountof time is approximately twenty four to thirty six hours.
 29. Thevascular access device of claim 23, wherein the liquid source is aliquid within a lumen extending through the body.
 30. The vascularaccess device of claim 29, further comprising a water soluble dye withinthe channel.
 31. The vascular access device of claim 30, wherein thechannel is divided into segments along its length, each segmentincluding a dye, the dye of each segment having a different color fromthe dye in the other segments.
 32. The vascular access device of claim23, wherein the liquid source is a liquid reservoir disposed on thebody.
 33. The vascular access device of claim 32, further comprising abreakable seal disposed between the liquid reservoir and the first endof the channel, such that when the breakable seal is broken, liquid fromthe liquid reservoir is in fluid communication with the channel.
 34. Thevascular access device of claim 32, wherein the liquid reservoir isdisposed within a compressible chamber.
 35. A vascular access devicecomprising: a body; a lumen within the body; a channel within the body,the channel having a first end, a second end, a length, and innerdimensions; a liquid absorbing material disposed within the channel; thefirst end of the channel being in fluid communication with the lumen;and the length and inner dimensions of the channel being configured sothat a liquid from the liquid source moves from the first end of thechannel through the liquid absorbing material to the second end of thechannel in approximately a predetermined amount of time.
 36. Thevascular access device of claim 35, further comprising a dye disposedwithin the channel;
 37. The vascular access device of claim 36, whereinthe dye is a water soluble dye.
 38. The vascular access device of claim36, wherein the dye is disposed within the liquid absorbing material.39. The vascular access device of claim 35, further comprising a widowdisposed between the second end of the channel and an externalenvironment, the channel being visible through the window.
 40. Avascular access device comprising: a body; a channel within the body,the channel having a first end, a second end, a length, and innerdimensions; a liquid absorbing material disposed within the channel; aliquid reservoir disposed near the first end of the channel; a breakableseal disposed between the liquid reservoir and the first end of thechannel, such that when the breakable seal is broken, liquid from theliquid reservoir is in fluid communication with the channel; the lengthand inner dimensions of the channel being configured so that a liquidfrom the liquid source moves from the first end of the channel throughthe liquid absorbing material to the second end of the channel inapproximately a predetermined amount of time.
 41. The vascular accessdevice of claim 40, wherein the liquid within the liquid reservoir is acolored liquid.
 42. The vascular access device of claim 40, furthercomprising a widow disposed between the second end of the channel and anexternal environment, the channel being visible through the window.